Table 3.
Number and percentage of participants with possibly or probably related unsolicited adverse events (AEs) following any vaccination (full analysis set).
| Group | 1.5/25 μg (N = 22) | 5.9/100 μg (N = 26) | Control (N = 24) |
|---|---|---|---|
| Any AE, n (%) | 13 (59) | 16 (62) | 12 (50) |
| Blood and lymphatic system disorders, n (%) | 2 (9) | 3 (12) | 1 (4) |
| Neutropenia | 2 (9) | 3 (12) | 1 (4) |
| Gastrointestinal disorders, n (%) | 3 (14) | 3 (12) | 0 |
| Abdominal pain | 0 | 1 (4) | 0 |
| Diarrhea | 2 (9) | 1 (4) | 0 |
| Nausea | 1 (5) | 1 (4) | 0 |
| Vomiting | 1 (5) | 0 | 0 |
| General disorders and administration site conditions, n (%) | 6 (27) | 8 (31) | 4 (17) |
| Chills | 0 | 1 (4) | 0 |
| Fatigue | 1 (5) | 2 (8) | 1 (4) |
| Induration | 0 | 1 (4) | 0 |
| Injection site pain | 6 (27) | 7 (27) | 1 (4) |
| Malaise | 1 (5) | 2 (8) | 1 (4) |
| Pyrexia | 0 | 0 | 1 (4) |
| Musculoskeletal and connective tissue disorders, n (%) | 6 (27) | 7 (27) | 8 (33) |
| Arthralgia | 0 | 1 (4) | 1 (4) |
| Limb discomfort | 5 (23) | 7 (27) | 6 (25) |
| Myalgia | 1 (5) | 0 | 2 (8) |
| Nervous system disorders, n (%) | 3 (14) | 6 (23) | 4 (17) |
| Dizziness | 1 (5) | 1 (4) | 1 (4) |
| Headache | 2 (9) | 6 (23) | 4 (17) |
N, number of exposed participants in each group; n (%), number (percentage) of participants in each category; 1.5/25 μg, 5.9/100 μg, participants who received the 1790GAHB vaccine with an O antigen/protein content of 1.5/25 and 5.9/100 μg, respectively, at days 1 and 29; Control, participants who received meningococcal vaccine against serogroups A, C, W, and Y at day 1 and tetanus, diphtheria, and acellular pertussis vaccine at day 29.